Job Description :
• Conduct the clinical study Audits: which include the planning & execution of all clinical study audits in compliance with Protocol, SOPs, ICH GCP, and applicable regulatory guidelines.
• Coordinating with CR department & represent the QA in inter department meetings.
• Preparation and review of Bioequivalence studies, Clinical trial SOPs.
• Preparation of training schedules and conduct the training programmes to departments on SOPs and quality system procedures.
• Verify various activities before and during conduct of a study such as screening of study participants, IP dispensing, dosing and sample storage etc.
• Verify Clinical data after completion of clinical studies for completion and correctness of documentation and review of case report forms clinical study reports and verification of final compiled report.
• Participates in the identification and development of SOPs and processes.
• Perform Internal Quality Audits: schedule, perform, and writes report and track monitoring responses and corrective actions.
• Preparing for regulatory Inspections
Experience: 0-1 Year
Education: B.Pharm, M.Pharm
Industry Type: CRO
Functional Area: Quality Analyst
Last Date: 25th November, 2016
Anacipher Clinical Research Organisation
3rd & 4th Floor, Mirra Kamshetty Mall, Near Doordarshan Bhavan,
Ramanthapur, Hyderabad – 500013.
Send your CV : firstname.lastname@example.org